A series of FDA recalls on “sartan” active ingredients made abroad has shaken the drug industry’s confidence in the manufacturing process used for the generic blood pressure medications. Now, with trade pressure ramping up, the Pentagon is eyeing China’s API production as a potential health crisis.
The Defense Health Agency (DHA) is scrutinizing increased Chinese production of the API behind a range of popular “sartan” drugs, including losartan and valsartan, as a health threat for military members who use the drugs. The worldwide recalls stemmed from API made by a Chinese supplier.
"The national security risks of increased Chinese dominance of the global API market cannot be overstated," Christopher Priest, acting deputy assistant director for healthcare operations and Tricare for the DHA, told a U.S.-China advisory panel last week in Washington.
The Pentagon’s heightened focus on Chinese API production comes as the two countries engage in an increasingly acrimonious “trade war” that has become a hallmark moment in President Donald Trump’s term in office. With a new round of tariffs on Chinese goods likely, the National Security Council is looking into Chinese drug manufacturing and trying to identify the most at-risk medications, according to Stars & Stripes.
The FDA launched a global recall in 2018 after a U.S. drug manufacturer found high levels of N-nitrosodimethylamine (NDMA) in the valsartan active ingredient it had bought from a Chinese supplier. Since then, the FDA discovered that NDMA, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA—all considered unsafe at certain levels—can be created during sartan drug manufacturing under certain conditions.
In early April, the FDA cleared 40 angiotensin II receptor blockers that are free of those three potentially carcinogenic compounds as a worldwide shortage in losartan continues to pinch the global market.
That losartan shortage led the FDA to back off its own impurity standards for losartan active ingredients in late March, freeing drugmakers to sell products with impurities above the prescribed level for six months.
The FDA argued that scientists believe the risks associated with the impurities are low to begin with and six months of patient exposure likely wouldn’t pose any new health concerns. The relaxed rules only applied to losartan and the impurity NMBA.